Home-based Resistance Training to Patients With Type 2 Diabetes

NCT04755660 | Completed Results

• 1 other identifier: 2020-11-004B
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare motivational interviews and self-efficacy theory-based exercise behavior and home-based resistance exercise (elastic band to non-elastic band) to improve physical activity, muscle strength, body composition, and self-efficacy of exercise in type 2 diabetic patients. The effectiveness of performance and exercise compliance.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, Type 2; Resistance exercise; Muscle strength

Outcome Measures

Primary Outcomes (1)

• Physical Activity

  Physical activity measured leisure-time physical activity for 7 days by Physical Activity Scale for the Elderly (PASE).PASE was self-administered occupational, household, and leisure physical activities. Participants were asked about the intensity, frequency, and duration of a variety of activities, including walking; strenuous, moderate, and light sports; muscle strength and endurance; occupational activities that included standing or walking; lawn work and gardening; caring for another person; home repairs; and heavy and light housework over the previous 7 days. The frequency and duration of each activity were multiplied by an empirically derived item weight and summed to compute the total PASE score activity.15 The PASE questions work-related, household, and leisure time activities for the 7 days preceding the interview. The score is continuous, ranges from 0 to 793, and higher values indicate a more active individual.

  Change from Baseline to 12 weeks

Secondary Outcomes (6)

• Hand Grip Strength(kg)

  Change from Baseline to 12 weeks

• Body Composition

  Change from Baseline to 12 weeks

• Self-efficacy

  Change from Baseline to 12 weeks

• Physical Performance_30-s Chair Stand Test.

  Change from Baseline to 12 weeks

• Hemoglobin A1c

  Change from Baseline to 12 weeks

Study Arms (3)

Exercise behavior change group (EBCG)

EXPERIMENTAL

Behavior Change Theory-based intervention + Resistance Exercise

Behavioral: Exercise behavior change for resistance exercise

Elastic band resistance exercise group( EBRG)

ACTIVE COMPARATOR

Elastic Band Resistance Exercise

Behavioral: Exercise behavior change for resistance exercise

Usual care (UC)

SHAM COMPARATOR

usual care: exercise education

Behavioral: Exercise behavior change for resistance exercise

Interventions

Exercise behavior change for resistance exercise BEHAVIORAL

The intervention includes motivational interviews and self-efficacy theory-based exercise behavior and home-based resistance exercise intervention (by Elastic Band or non- Elastic Band ), and 3 follow-up telephone calls. The usual care group will receive exercise counseling.

Elastic band resistance exercise group( EBRG); Exercise behavior change group (EBCG); Usual care (UC)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diabetes type 2
• age \>50 years old
• sedentary lifestyle (PASE questionnaire leisure time physical activities score female \<30 points, male \<40 points)

You may not qualify if:

• severe congestive heart failure (New York Heart Association Functional Class III and IV)
• severe renal failure (estimated Glomerular Filtration Rate \< 15 mL/min/1.73m2)
• stroke ((The National Institutes of Health Stroke Scale \> 15)
• Peripheral Arterial Occlusive Disease
• Foot ulcer over 6 month
• Severe muscle diseases and rheumatoid arthritis
• Cognitive or mental disorders who cannot understand and cooperate with the exercise plan
• those who are accessed by the doctor to be avoided for exercise

Sponsors & Collaborators

• National Taipei University of Nursing and Health Sciences: lead
• Taiwan Nurses Association: collaborator

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

Location

Related Publications (5)

• Mori H, Kuroda A, Matsuhisa M. Clinical impact of sarcopenia and dynapenia on diabetes. Diabetol Int. 2019 Jun 19;10(3):183-187. doi: 10.1007/s13340-019-00400-1. eCollection 2019 Jul.

  PMID: 31275784 BACKGROUND

• Nomura T, Kawae T, Kataoka H, Ikeda Y. Aging, physical activity, and diabetic complications related to loss of muscle strength in patients with type 2 diabetes. Phys Ther Res. 2018 Nov 30;21(2):33-38. doi: 10.1298/ptr.R0002. eCollection 2018.

  PMID: 30697507 BACKGROUND

• Lee J, Kim D, Kim C. Resistance Training for Glycemic Control, Muscular Strength, and Lean Body Mass in Old Type 2 Diabetic Patients: A Meta-Analysis. Diabetes Ther. 2017 Jun;8(3):459-473. doi: 10.1007/s13300-017-0258-3. Epub 2017 Apr 5.

  PMID: 28382531 BACKGROUND

• Mogre V, Johnson NA, Tzelepis F, Paul C. Barriers to diabetic self-care: A qualitative study of patients' and healthcare providers' perspectives. J Clin Nurs. 2019 Jun;28(11-12):2296-2308. doi: 10.1111/jocn.14835. Epub 2019 Mar 6.

  PMID: 30791160 BACKGROUND

• Kim YH, Kim KI, Paik NJ, Kim KW, Jang HC, Lim JY. Muscle strength: A better index of low physical performance than muscle mass in older adults. Geriatr Gerontol Int. 2016 May;16(5):577-85. doi: 10.1111/ggi.12514. Epub 2015 May 28.

  PMID: 26017097 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Tingru Lin
• Organization: National Taipei University of Nursing and Health Sciences

tingru@ntunhs.edu.tw

886-2-28227101

Study Officials

• Tsae -Jyy Wang, Professor

  National Taipei University of Nursing and Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: single
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized

Study Record Dates

• First Submitted: January 31, 2021
• First Posted: February 16, 2021
• Study Start: March 15, 2021
• Primary Completion: December 7, 2021
• Study Completion: December 30, 2021
• Last Updated: February 18, 2025
• Results First Posted: February 18, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)